FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50192253068830
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
8884720265E
Catalog number
8884720265E
Device description
Gastrostomy Feeding Tube With ENFit Y-Port 26 Fr/Ch (8.7 mm) with 20 mL Balloon
Published
2026-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PIFGastrointestinal Tubes with Enteral Specific Connectors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PIFGastrointestinal Tubes With Enteral Specific ConnectorsGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253068830PackageGS15In Commercial Distribution
10192253068832PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225306883050192253068830
1019225306883210192253068832

GMDN Terms#

Term, Definition table
TermDefinition
Gastrostomy tubeA thin, flexible, percutaneous, hollow tube which may include additional external components (e.g., external tubing, syringe) intended to be percutaneously inserted into the stomach to feed a patient with a physical disability that prevents oral feeding (e.g., a birth defect of the stomach), and/or provide drainage/decompression of the stomach when it is necessary to bypass an obstruction of the stomach outlet into the small intestine. Although noninvasive disposable enteral feeding components may be included, surgical instruments and pharmaceutical agents are not included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge26French
Total Volume20Milliliter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842071153038AMT MiniONE Extension SetAPPLIED MEDICAL TECHNOLOGY, INC.PIF2026-03-23
50192253012505Salem SumpCardinal Health 200, LLCPIF2026-03-19
50192253012987Salem SumpCardinal Health 200, LLCPIF2026-03-19
50192253068786CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
50192253068793CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
50192253068816CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
50192253068823CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
50192253011447CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
50192253011461CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
50192253011515CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
50192253011553CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
50192253011577CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
50192253011614CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
05060999351571EnteralGBUK ENTERAL LIMITEDPIF2025-08-20
05060999351601EnteralGBUK ENTERAL LIMITEDPIF2025-08-20
05060999351632EnteralGBUK ENTERAL LIMITEDPIF2025-08-20
05060999351670EnteralGBUK ENTERAL LIMITEDPIF2025-08-20
20813939024917VESCOXERIDIEM MEDICAL DEVICES, INC.PIF2025-06-16
20813939024924VESCOXERIDIEM MEDICAL DEVICES, INC.PIF2025-06-16
20813939024931VESCOXERIDIEM MEDICAL DEVICES, INC.PIF2025-06-16
20813939024948VESCOXERIDIEM MEDICAL DEVICES, INC.PIF2025-06-16
20813939024955VESCOXERIDIEM MEDICAL DEVICES, INC.PIF2025-06-16
20813939024962VESCOXERIDIEM MEDICAL DEVICES, INC.PIF2025-06-16
00850016172488KBMEDKB Medical (group), Inc.PIF2025-05-21
00850016172495KBMEDKB Medical (group), Inc.PIF2025-05-21
50192253007570ArgyleCardinal Health 200, LLCPIF2025-04-24
50192253007594ArgyleCardinal Health 200, LLCPIF2025-04-24
50192253007617ArgyleCardinal Health 200, LLCPIF2025-04-24
50192253007631ArgyleCardinal Health 200, LLCPIF2025-04-24
50192253007655ArgyleCardinal Health 200, LLCPIF2025-04-24